UMIN-CTR Clinical Trial

Basic information
Public title	The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Acronym	The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Scientific Title	The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Scientific Title:Acronym	The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Region	Japan

Condition
Condition	Social anxiety disorder
Classification by specialty	Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the effects of a counseling-type CBT program, which is conventionally used as psychotherapy, and a CBT program that focuses on cognitive intervention to reduce the burden of video feedback.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japanese version of Liebowitz Social Anxiety Scale
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Cognitive behavior therapy: 8 times sessions 1 time video feedback
Interventions/Control_2	Cognitive behavior therapy: 8 times sessions 3 times video feedback
Interventions/Control_3	Questionnaire survey
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients diagnosed with social anxiety
Key exclusion criteria	High Suicide Risk Individuals with severe depressive symptoms Individuals judged difficult by the attending physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Shirotsuki
Organization	Musashino University
Division name	Faculty of Human Sciences
Zip code	1358181
Address	3-3-3, Ariake, Koto-ku, Tokyo
TEL	0355307624
Email	kenshiro@musashino-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Shirotsuki
Organization	Musashino University
Division name	Faculty of Human Sciences
Zip code	1358181
Address	3-3-3, Ariake, Koto-ku, Tokyo
TEL	0355307624
Homepage URL
Email	kenshiro@musashino-u.ac.jp

Sponsor
Institute	Musashino University
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Human Sciences,Musashino University, Research Ethics Committee
Address	3-3-3, Ariake, Koto-ku, Tokyo
Tel	03-5530-7448
Email	masako_k@musashino-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 13 Day
Date of IRB	2018 Year 04 Month 23 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 25 Day
Last modified on	2022 Year 09 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044754